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Formulation parameters governing sustained protein delivery from degradable viscous liquid aliphatic polycarbonates
Sara Mohajeri1, Jonah Burke-Kleinman2, Donald H Maurice2
1Department of Chemical Engineering, Queen's University, Kingston, Ontario K7L 3N6, Canada; Human Mobility Research Centre, Kingston General Hospital, Kingston, Ontario K7L 2V7, Canada.
International Journal of Pharmaceutics
|October 12, 2020
Summary
A new degradable polymer, poly(trimethylene carbonate-co-5-hydroxy trimethylene carbonate), offers sustained protein delivery. This innovative material maintains a neutral pH, ideal for acid-sensitive protein therapeutics.
Area of Science:
- Biomaterials Science
- Polymer Chemistry
- Drug Delivery Systems
Background:
- Viscous liquid degradable polymers are effective as drug depots for sustained protein delivery.
- Maintaining a neutral micro-environmental pH is crucial for acid-sensitive protein therapeutics.
- Aliphatic polycarbonates offer potential for controlled drug release applications.
Purpose of the Study:
- To develop and characterize a novel aliphatic polycarbonate for sustained protein delivery.
- To investigate the pH stability and protein release mechanism of the new copolymer.
- To demonstrate the suitability of the copolymer for delivering bioactive protein therapeutics.
Main Methods:
- Synthesis of poly(trimethylene carbonate-co-5-hydroxy trimethylene carbonate).
- Degradation studies to assess micro-environmental pH.
- In vitro protein release assays using vascular endothelial growth factor (VEGF).
- Analysis of factors influencing protein release, including polymer hydrophobicity, molecular weight, initiator, protein solubility, size, and isoelectric point.
Main Results:
- The novel copolymer, poly(trimethylene carbonate-co-5-hydroxy trimethylene carbonate), degrades while maintaining a near-neutral micro-environmental pH.
- Protein release mechanism involves super-hydrated regions due to osmotic activity from dissolved protein particles.
- Protein release rate is controllable via polymer hydrophobicity (molecular weight, initiator) and protein solubility.
- Protein molecular size and isoelectric point were found to be less influential on release rates.
Conclusions:
- The developed aliphatic polycarbonate copolymer is well-suited for sustained delivery of acid-sensitive protein therapeutics.
- The controlled release mechanism offers a tunable platform for protein drug depots.
- Formulations demonstrated successful prolonged delivery of bioactive vascular endothelial growth factor, highlighting therapeutic potential.
